OnPointTM 1.2mm Scope System

Anticipate. Innovate.TM

Product Overview

The OnPoint™ 1.2 mm Scope System is an innovative breakthrough that provides minimally invasive visualization of the temporomandibular joint in the comfort and convenience of an office-based setting.

The OnPoint system has been designed to provide visualization for minimally invasive diagnostic and operative procedures. The TMJ arthroscope is a small, tube-like camera that projects the image of the jointonto a monitor, allowing the surgeon to view the insidethe joint without making any large incisions. TheOnPoint system can be used in addition to a MRI scan,or alone for the surgeon to determine the next plan of action for each patient.

The OnPoint system allows the surgeon to view theinside of the temporomandibular joint in their officeinstead of having to perform exploratory surgery in theoperating room. With a scope diameter no largerthan an 18 gauge needle, this state-of-the-art imagingsystem allows for an accurate and less invasiveprocedure.

The OnPoint™ System Utilizes:• System hardware, software, and hand-piece

• Disposable scope

• Disposable Instrumentation: cannula, trocar, obturator, and cannula plug

• Procedure Kit including sterile supply items needed for the procedure

Scope Hand-PieceThe OnPoint™ 1.2mm Scope System incorporates a camera anda light source into the ergonomic hand-piece. One cable is needed to connect the hand-piece to the main unit, eliminating separate camera and light cords. The button on thehand-piece allows still image capture and video recording. To capture a picture, press the button once. To begin recording video, hold the button down for more than 2 seconds and pushthe button again once you have finished recording.

1.2mm Disposable ScopeThe disposable, fiber-optic scope is approximately the size of an18-gauge needle and is sterile packaged for single use. The scope snaps onto the hand-piece and features an integrated sterile hand-piece drape.

Disposable InstrumentsA set of disposable instruments are included with the disposable scope. Instruments included are a sterile single-use cannula, trocar, obturator, and cannula plug. The instrument components are designed with a molded plastic body and stainless steel sheath providing rigidity. The cannula has an outside diameterof 1.9mm and a luer port on its body to allow irrigation. The plug can be used to seal the scope port on the cannula forintra-articular injection. Additional disposable instrument setsmay be purchased separately.

2. Drape and prepare patient.

7. Once the procedure is finished, the physician determines the nextcourse of action for the patient.

1. Open procedure kit.

6. Place the 1.2mm scope and perform diagnostic arthroscopy. Once the physician makes a diagnosis, the scope and cannula may be removed.

5. Insufflate the joint space.

3. Inject local anesthetic into the planned puncture point.

4. Open scope and sterile instruments.

Biomet Microfixation does not practice medicine and does not recommend this product or surgical guideline on a specific patient.

Suggested Procedural Setup

Physician BenefitsThe OnPoint™ 1.2mm Scope System provides visualization and illumination which allows physicians to perform medical imaging and diagnostic services to bring a “value-added” element to their practices by setting the surgeon apart from others in the specialty.

Micro-Invasive • The scope has an outside diameter of 1.2mm (~18 gauge needle) • Only a single portal with a small puncture point is required for the procedure

Cutting Edge Technology • All digital imaging platform • Direct, enhanced visualization of pathology • Video and audio capture capabilities

Active Diagnostic Tool in the Hands of the Physician • Can be used to clarify what is seen on an MRI • Provides visualization of the TMJ • Disposable instruments provide introduction of fluid into the joint during visualization

Determine Course of Action During Patient’s Consultation • Provides immediate intra-articular visualization • Reduces the need for second opinions • Visualization provides more information than a blind lysis and lavage

Patient Benefits • Immediate results • Only a local anesthetic is required • Convenience - patient can be seen in the physician’s office • Surgeon and patient are able to directly visualize the joint together and discuss possible treatment • Pictures or models are used to confirm and understand what is seen • Patient can be provided with video and pictures to share information obtained during the procedure 75% smaller than a traditional scope

Evolution of the ArthroscopeThe 1.2mm diameter of the OnPoint™ Diagnostic TMJ Scope is approximately 75% smaller than the traditional 4.5mm glass rod scope. Its fiber-optic design tolerates flexion to help avoid tissue trauma.

System Features

Xenon Fiber Optic Light SourceA proprietary xenon arc lamp incorporates an enhanced reflector, and delivers near 175-watt illumination performance for outstanding image quality.

Integrated Video Display with Multiple OutputsThe OnPoint high-resolution 6.4” LCD monitor combines the performance of the Xenon Fiber Optic Light Source and High Resolution Camera System to deliver a brilliant,high-resolution video image for clear detail recognition. Multiple output options on the OnPoint unit allow you to connect larger external image monitors, video printers and video recording devices.

High-Resolution Camera SystemThe OnPoint camera is a high-resolution 480-line digital camera. A proprietary single cable design eliminates the complexity and cost of the old dual cable system approach.

Media Storage and Efficient Data TransferUsing the universal CompactFlash® media format, MediaCapture USB enables users to quickly and conveniently document their procedures. User can connect directly to a computer via USB and use the OnPoint system to browse captured media, or capture still images and video directly to your practice management software running on Windows 2000 or Windows XP.

The OnPoint™ 1.2mm Scope System offers the next generation of innovative technology that combines the function of an arthroscopy tower with the convenienceof a laptop sized unit. OnPoint system has the capability to capture still images, full-resolution video, and audio-tagged footage. The OnPoint system combinesseveral essential surgical features into a single compact and portable package:

Optic Light Source Data TransferCamera System and Scope

Ordering InformationOnPoint™ 1.2mm Scope System

DescriptionPart #

OnPoint System Base Unit

1.2mm Scope with instruments

Scope Procedure Kit

Scope Procedure Kit* (Europe)

Instruments Only

Memory Card Converter

Hand-piece

24-3200

24-3000

24-3050

24-3055

24-3001

24-3201

24-3100

Product DetailsItem Notes

The OnPoint system accepts any PS2 connection.

HP "a" System Printer(a526,a626,a826)

Logitech CordlessDesktop EX110

Anthro Carts

a826 has faster print times, large touch screenand editing features

Keyboard

Cart

Printer

www.anthro.com

Additional AccessoriesBiomet Microfixation does not provide, sell or distribute the following accessories.

Scope Procedure KitPart # 24-3050Part # 24-3055* (Europe)

Qty Description

1 60ml Luer Lock Syringe

4 OR towels

4 Towel Clamps**

5 Cotton Balls

2 Dot Bandages

3 Chloraprep® Swabstick**

1 Extension Tubing

2 Facial Drapes

1 Syringe Pumping Set

1 Bilateral Facial Ice Pack (Jaw Bra)

2 22GX1.5” Needles

1 Skin Marker with Ruler

*EU Kit is for use in Europe **Not included in the EU-Kit

For more information on the OnPointTM 1.2mm Scope System or other related TMJ products, please contact us at:

GLOBAL HEADQUARTERS1520 Tradeport Drive • Jacksonville, FL 32218-2480

Tel (904) 741-4400 • Toll-Free (800) 874-7711 • Fax (904) 741-4500 • Order Fax (904) 741-3059www.biometmicrofixation.com

EUROPEToermalijnring 600 • 3316 LC Dordrecht • The Netherlands

Tel +31 78 629 29 10 • Fax +31 78 629 29 12e-mail: europe@biomet.com

What fascinates you about the body is also what drives us. That’s why we’re always pushing the boundaries of engineering to make products that help you keep the human form as glorious as it was intended. To learn more about our breadth of

products, call 800-874-7711 or visit us online at biometmicrofixation.com. We’d love to join you in a conversation about the future.

This brochure was prepared in conjunction with a licensed physician. Biomet Microfixation, as the distributor of this device, does not practice medicine. The surgeon who performs any implant procedure must determine the appropriate device and surgical procedure for each individual patient. Devices shown in this brochure may not be cleared or licensed for use or sale in your individual country. Please contact your local distributor for

information regarding availability of this product. Information contained in this brochure is intended for surgeon or distributor information only and is not intended for patient distribution. All surgeries carry risks.For additional information, please see package insert, or visit our web site at www.biometmicrofixation.com or call 1-800-874-7711.

OnPointTM is manufactured by BioVision and is distributed by Biomet Microfixation

OnPointTM is a registered trademark of Biomet.Chloraprep® is a registered trademark of Cardinal Health.r01k0809 BMF00-2175